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DAT SPECT and Procedural Motor Skills in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Procedural Motor Skills with mirror-drawing of figures
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria for PD group:

  • Age > 18 year-old
  • Diagnosis of PD with onset <2 years from enrollment
  • Available DAT SPECT performed in Geneva University Hospitals <6 months before inclusion

Inclusion criteria for control group:

Age- and sex-matched control patients

  • Age > 18 year-old
  • No known neurological condition interfering with motor and cognitive abilities
  • No medication interfering with central nervous system (including antidepressants, antipsychotics, hypnotics)

Exclusion criteria for both groups:

  • Major depressive state (Hospital Anxiety and Depression scale ≥11 for depression score)
  • Cognitive decline (Mini-Mental Score ≤ 22/30)
  • Debilitating tremor (Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - rest, postural and action tremor ≥2/4)
  • Significant akinesia (MDS-UPDRS III hand brady-akinesia score ≥2/4)

Sites / Locations

  • Division of Neurorehabilitation, Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parkinson's disease

Control group

Arm Description

Outcomes

Primary Outcome Measures

Procedural motor performance (error and time) in PD group
Evaluation of error rate and speed for completion of mirror-drawing of star-shaped figures

Secondary Outcome Measures

Resting state EEG connectivity in PD and control groups
Evaluation of resting state EEG connectivity in both groups
Difference >20% in error rate and speed improvement in control and PD groups
Evaluation of a >20%-difference between PD and control groups in terms of speed and error rate for the successive procedural motor task trials

Full Information

First Posted
March 6, 2017
Last Updated
July 19, 2017
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT03076307
Brief Title
DAT SPECT and Procedural Motor Skills in Parkinson's Disease
Official Title
Correlation of Procedural Motor Skills Impairment and 123I-FP-CIT SPECT Uptake in Patients With Early Parkinson's Disease: a Case-control Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
May 20, 2017 (Actual)
Study Completion Date
July 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with Parkinson's disease (PD) are known to be affected by subtle cognitive impairment early in the disease course, mostly in the executive field. Procedural motor skills, mainly controlled by the basal ganglia associative loop (in particular dorsal caudate nucleus) (Rodriguez-Oroz et al., 2009), have also been studied in patients with PD (Schnider et al., 1995; Muslimovic et al., 2007; Terpening et al., 2013). However, the correlation of dopaminergic 123I-FP-CIT SPECT imaging and cognitive impairment has not been assessed. One reason is the absence of reference values for striatal uptake until recently. Last year, the investigators established local uptake reference values for DAT imaging based on a large cohort of subjects with non-degenerative conditions (Nicastro et al., 2016) and can therefore use these values to precisely assess uptake loss in patients with PD. With the present study, the investigators expect to enroll patients with early PD for whom a 123I-FP-CIT SPECT has been previously performed in the center. Subjects will perform a specific motor task based on mirror-drawing of star-shaped figures. This will be done by inverting the direction of horizontal/vertical computer mouse movements on the screen. Speed and error rates will be assessed for patients as well as healthy control subjects. Correlation with striatal SPECT uptake, especially caudate nucleus uptake, will be analyzed for PD patients. In addition, resting-state EEG will be performed for all subjects. General medication and dopaminergic drugs in particular, whenever used, will not be discontinued. For all subjects enrolled in the study, cognitive and neurological examination will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's disease
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Procedural Motor Skills with mirror-drawing of figures
Intervention Description
Evaluation of error rate and speed for completion of a procedural motor task
Primary Outcome Measure Information:
Title
Procedural motor performance (error and time) in PD group
Description
Evaluation of error rate and speed for completion of mirror-drawing of star-shaped figures
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Resting state EEG connectivity in PD and control groups
Description
Evaluation of resting state EEG connectivity in both groups
Time Frame
2 days
Title
Difference >20% in error rate and speed improvement in control and PD groups
Description
Evaluation of a >20%-difference between PD and control groups in terms of speed and error rate for the successive procedural motor task trials
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for PD group: Age > 18 year-old Diagnosis of PD with onset <2 years from enrollment Available DAT SPECT performed in Geneva University Hospitals <6 months before inclusion Inclusion criteria for control group: Age- and sex-matched control patients Age > 18 year-old No known neurological condition interfering with motor and cognitive abilities No medication interfering with central nervous system (including antidepressants, antipsychotics, hypnotics) Exclusion criteria for both groups: Major depressive state (Hospital Anxiety and Depression scale ≥11 for depression score) Cognitive decline (Mini-Mental Score ≤ 22/30) Debilitating tremor (Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - rest, postural and action tremor ≥2/4) Significant akinesia (MDS-UPDRS III hand brady-akinesia score ≥2/4)
Facility Information:
Facility Name
Division of Neurorehabilitation, Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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DAT SPECT and Procedural Motor Skills in Parkinson's Disease

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